Background. The aim was to evaluate the analgesic efficacy and safety of the dexketoprofen/tramadol 25 mg/75 mg fixed-dose combination vs dexketoprofen (25 mg) and tramadol (100 mg) in moderate-to-severe acute pain after total hip arthroplasty.Methods. This was a randomized, double-blind, parallel-group study in patients experiencing pain of at least moderate intensity on the day after surgery, compared with placebo at first administration to validate the pain model. The study drug was administered orally every 8 h throughout a 5 day period. Rescue medication, metamizole 500 mg, was available during the treatment period. The evaluation of efficacy was based on patient assessments of pain intensity and pain relief. The primary end point was the mean sum of the pain intensity difference values throughout the first 8 h (SPID8).Results. Overall, 641 patients, mean age 62 (range 29–80) yr, were analysed; mean (sd) values of SPID8 were 247 (157) for dexketoprofen/tramadol, 209 (155) for dexketoprofen, 205 (146) for tramadol, and 151 (159) for placebo. The primary analysis confirmed the superiority of the combination over dexketoprofen 25 mg (P=0.019; 95% confidence interval 6.4–73) and tramadol 100 mg (P=0.012; 95% confidence interval 9.5–76). The single components were superior to placebo (P<0.05), confirming model sensitivity. Most secondary analyses supported the superiority of the combination. The incidence of adverse drug reactions was low and similar among active treatment groups.Conclusion. The efficacy results confirmed the superiority of dexketoprofen/tramadol over its single components, even at higher doses (tramadol), with a safety profile fully in line with that previously known for these agents in monotherapy.Clinical trial registration. EudraCT 2012-004548-31 ();ClinicalTrials.gov NCT01902134 ().
The aim: To analyse long-term results of treating patients with open fractures of low-leg bones within a specific time period and to describe concomitant problems. Materials and methods: A retrospective study was carried out to evaluate the results of the final treatment of patients after one year and after five years. Patients were divided into two groups. Group I included 47 (61.84%) patients for whom the treatment method was changed from external fixation to internal fixation. Group II included 29 (38.16%) patients for whom the final treatment of an open fracture was performed with an external fixation device without changing the method. The study exclusion criteria were patients under 18 years old and patients with gunshot fractures of the lower leg bones. Results: Patient treatment included initial surgical debridement and fracture stabilization with external fixation devices. In all patients, wound healing occurred within 30 days (on average, 24 ± 4.5 days). When evaluating the treatment of patients in group I, 32 (68.09%) of them underwent a one-stage removal of an external fixation device and osteosynthesis of fragments during the first 7-10 days. In 3 (20.0%) patients, osteosynthesis was performed with an intramedullary locking nail, in 12 (80.0%) patients – with a plate. The decision to change the fixation method was made taking into account clinical and laboratory parameters. It is noted that the treatment of patients with type III open fractures of the lower leg bones according to the Gustilo-Andersen classification, provided that the method of external fixation is replaced with an internal one, gives better results compared to osteosynthesis with external fixation devices. Conclusions: Treatment of patients with high-energy injuries of the lower leg bones is a long-term process. It is possible to improve the therapy efficiency by changing the fixation method from external to internal one. In this regard, the main evaluative characteristics are such indicators as uncomplicated wound healing combined with the absence of laboratory and clinical signs of inflammation.
Цель. Изучить путем сравнения результаты применения при ОП классической тактики и тактики многоэтапного хирургического лечения, обсудить вопросы выбора метода фиксации ОП и возможности раннего закрытия обширных ран и дефектов мягких тканей. Материалы и методы. Проанализированы результаты лечения 286 пациентов с ОП костей верхних и нижних конечностей в ортопедо-травматологическом центре Киевской областной клинической больницы за период с 2008 по 2016 г. Применяли классические методы и тактику многоэтапного хирургического лечения. Результаты. Оценивали результаты хирургического лечения ОП костей верхних и нижних конечностей с использованием балльной шкалы Neer-Grantham-Shelton. Хорошие результаты получены у 54,84% пациентов 1-й группы и у 80,28% пациентов 2-й группы. Выводы. Успех лечения ОП зависит от ранней госпитализации, ранней радикальной хирургической обработки, стабильной фиксации сломанной кости, применения рациональных доз антибиотиков, коррекции иммунологического статуса. Одними из наиболее спорных и нерешенных остаются проблемы выбора метода фиксации ОП и раннего закрытия раны.
областной рады «Киевская областная клиническая больница». Украина 2 Национальная медицинская академия последипломного образования им. П. Л. Шупика, Киев. Украина
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